None listed
Conditions
Brief summary
Non Alcoholic Fatty Liver Disease (NAFLD) is a well described complication of type 2 diabetes. It is a disease with a broad spectrum of severity with the most aggressive form of it Non Alcoholic Steato-Hepatitis (NASH) often progressing to liver cirrhosis. Up until now the liver biopsy had been the gold standard in determining the stage of liver disease (or fibrosis) in such patients however a liver biopsy is costly, invasive and associated with complications including death. In recent years a new technique called fibroscan (Transient Elastography) has been validated as a non-invasive method of measuring liver fibrosis .Fibroscan(Transient Elastography) works by transmitting a vibration through the liver with the aid of ultrasound , this gives an impression of how stiff the liver is and liver stiffness can be directly equated to liver fibrosis. New blood markers are also now available which can accurately estimate degrees of liver fibrosis and add to traditional methods of assessing for liver disease. No studies as of yet have been done in assessing the utility of the fibroscan(Transient Elastography) and serum fibrosis markers in a type 2 diabetic population.
Interventions
Transient elastography(T.E)- liver stiffness which equates to liver fibrosis will be measured using T.E. T.E is an ultrasound like device which is placed over the liver and sends a vibration through the liver.The quicker the vibration passes through the liver the more fibrosed (or stiff) the liver is. It is a painless procedure lasting 10 minutes approximately.There are no associated adverse events.A total of 3 fibroscansessions will take place on each patient.The first at baseline then at 12 mo
Transient elastography(T.E)- liver stiffness which equates to liver fibrosis will be measured using T.E. T.E is an ultrasound like device which is placed over the liver and sends a vibration through the liver.The quicker the vibration passes through the liver the more fibrosed (or stiff) the liver is. It is a painless procedure lasting 10 minutes approximately.There are no associated adverse events.A total of 3 fibroscansessions will take place on each patient.The first at baseline then at 12 months,then at 24months. Readings are measured in kilopascals. Participants who have had liver biopsies in the past 12 months will have their T.E measurements compared to the biopsy result. Participants who have T.E readings indicating significant liver fibrosis(>7.5 Kilopascals) will be offered a liver biopsy to assess the severity of their liver disease if they have not had one in the last 12 months.Liver biopsy will be performed only once in these patients after the baseline transient elastography exam.Patients for liver biopsy will be admitted to the Alfred hospital medical day unit and taken to the radiology department.Liver biopsy will be carried out using local anaesthetic to the right lower rib spaces and sedation(midazolam).Ultrasound guidance will be used and a liver biopsy needle passed into the liver.Patients will be observed after the procedure in the medical day unit for 4 hours.A friend or family member will be requested to take the patient home
Sponsors
The Alfred Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Type 2 diabetes
Exclusion criteria
Body Mass Index(BMI)>35 Bleeding disorder Creatinine>200 International Normalised Ratio(INR)>1.5 Platelets<75 Anti-platelet agent use Major medical co-morbidities
Outcome results
None listed